Federal Register notice: FDA sends to OMB an information collection extension for drug Medication Guide Requirements.
National Center for Health Research president Diana Zuckerman says FDA was wrong to not make public an adverse event summary reporting system it allow...
CBER director Peter Marks says his public criticism of Novartis Zolgensma data manipulation was intended to maintain public trust in gene therapies.
FDA grants Astellas Pharma and Pfizer a priority review for their supplemental NDA for Xtandi (enzalutamide) for treating men with metastatic hormone-...
Federal Register notice: FDA seeks comments on an information collection extension for Patent Term Restoration; Due Diligence Petitions; Filing, Forma...
BioElectronics files a 510(k) that seeks expanded clearance for its ActiPatch Musculoskeletal Pain Therapy for adjunctive treatment of musculoskeletal...
Endo and Allergan agree to pay $15 million to settle a suit by two Ohio counties accusing several drug companies and drug distributors of being respon...
Sen. Gary Peters asks FDA acting commissioner Ned Sharpless to answer questions on the agencys current and future efforts to address drug shortages.